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Evaluation of the benefit and safety of Localized Tissue Hydration (LTH) in the management of chronic common low back pain: Non-randomized single-center phase II study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510625-25-00
Enrollment
29
Registered
2024-05-29
Start date
2024-11-14
Completion date
Unknown
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic common low back pain

Brief summary

Success rate after Localized Tissue Hydration (LHT) treatment combined with standard care, defined by a reduction in the EVN score of at least 30% between M0 and M6. The EVN is a scale ranging from 0 to 10. It will be completed at the inclusion visit (M0) and at the follow-up visits after the end of treatment (M3 and M6). The primary endpoint will be collected at the M6 ​​follow-up visit.

Interventions

DRUGCHLORURE DE SODIUM FRESENIUS 0
DRUG9 %
DRUGsolution pour perfusion

Sponsors

Groupement De Cooperation Sanitaire Ramsay Generale De Sante Pour L'enseignement Et La Recherche
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Success rate after Localized Tissue Hydration (LHT) treatment combined with standard care, defined by a reduction in the EVN score of at least 30% between M0 and M6. The EVN is a scale ranging from 0 to 10. It will be completed at the inclusion visit (M0) and at the follow-up visits after the end of treatment (M3 and M6). The primary endpoint will be collected at the M6 ​​follow-up visit.—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026